Domestic ViolenceNCT05917730
Manual of Emotional Regulation and Interpersonal Abilities in Children and Adolescents Group Therapy
An observational study of Domestic Violence and Psychotherapy, Group, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
Purpose: Domestic violence (DV) is a mental health problem that affects children and adolescents. Widespread evidence suggests that witnessing DV has physical and mental health consequences. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Domestic Violence, Psychotherapy, Group, Witness
- What is being tested?
- Emotional Regulation and Interpersonal Abilities group Therapy (MERITA)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to Jun 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient of a Child and Youth Mental Health Center.
Who may be able to join
- Patient of a Child and Youth Mental Health Center.
- Diagnosis of non-severe mental disorder according to DSM-5 (see exclusion criteria).
- Witness to violence at least in the last two years. A witness to violence is defined at least one of these characteristics (Holden, 2003; Suderman 1999): a) ocular witness of the violence; b) hear violent words or acts when she is in a nearby room; c) living the consequences of the violence without him having seen or heard anything, for example, when he finds that his mother is hurt, that she cries, that she tells him what has happened and that she wants to leave the house, or when he lives the police visit.
- Informed consent of the study signed by the guardian or legal representative.
Who cannot join
- No signing the informed consent.
- Diagnosis of autism spectrum disorder, active psychotic disorders (schizophrenia, schizophreniform, schizoaffective, brief psychotic disorder, induced psychotic disorder), and severe eating disorder.
- Reason for consultation of forensic evaluation.
- Lack of clear collaboration of adults.
- IQ < 70.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre de Salut Mental Infantojuvenil
Cornellà de Llobregat, Barcelona, 08940
About this study
Official title: Clinical Trial for Promoting Emotional Regulation and Interpersonal Skills (MERITA) in Children and Adolescents Witnesses of Domestic Violence
Purpose:
Domestic violence (DV) is a mental health problem that affects children and adolescents. Widespread evidence suggests that witnessing DV has physical and mental health consequences. 19% of children and adolescents cared for in Children, and Youth Mental Health Centers in Catalonia declare having witnessed DV between their parents. However, there are low specialized therapeutic tools to intervene effectively. In this line, the research team of the current project adapted and manualized a group treatment designed to treat children and adolescents between 8 and 16 years old witnesses of DV on an outpatient basis called: 'Manual of Emotional Regulation and Interpersonal Abilities group Therapy - MERITA'. The treatment main aim is to improve the emotional regulation and interpersonal skills of children and adolescents who have witnessed DV. We carried out a pilot study of MERITA (Lacasa et al., 2016) where we obtained promising results. Now, we want to carry out this study to improve methodological limitations by increasing the sample size. We have added a waiting list for assigning patients in different arms (MERITA intervention vs. treatment as usual as control group), as well as we improved the assessment (pre, post, and follow-ups) using several scales with good psychometric properties.
Read more
Aims:
The aim of this trial is twofold: firstly, to assess the effectiveness of Emotional Regulation and Interpersonal Abilities group Therapy (MERITA) in children and adolescents who are witnesses of DV and treated at the Infant and dolescent mental health center (TAU); and secondly, to analyze the differences (MERITA vs only TAU) on traumatic, depressive and anxious symptomatology, emotional dysregulation, interpersonal difficulties, externalizing and internalizing symptoms, somatic complaints, prosocial behavior, attachment, and family functioning. Specifically, MERITA will be compared to TAU alone (post and 3-month follow-up).
Methods
Design:
Trail with two arms:
- MERITA + TAU (intervention group)
- TAU (control group)
Sample:
The necessary sample size to detect statistically significant differences between the groups has been calculated using the G*Power: with a minimum effect size (0.50), a significance level of 5% and a power of 80%. A minimum of 36 participants would be required.
Read the detailed description
This clinical trial will be carried out with a group of children and adolescents who are witnesses of DV (between 8 and 16 years old). They will receive the MERITA treatment (together with TAU) and the other group will receive only TAU (control group).
The MERITA treatment consists of weekly 12 sessions of 75 minutes each. MERITA aims to improve emotional regulation and coping abilities, as well as promoting interpersonal skills and secure attachment.
After getting promising results from our previous pilot study of MERITA, the current project aims to validate, through a clinical trial with a control group, the MERIT treatment in minors who witness violence. To do this, children and adolescents who have undergone the MERIT will be compared with another group who receives other psychological and social approaches (treatment as usual), with other children and adolescents (same age and sex) who have only received treatment as usual.
The MERITA + TAU group and the TAU group will perform the following assessment: before treatment (baseline or pretreatment), after treatment (posttreatment), and at three months of follow-up. Specifically, the MERITA + TAU group will conduct two more assessments: at 6-month follow-up and one year of follow-up.
For ethical reasons, all patients will have the opportunity to use the MERITA treatment. Thus, the minors who were TAU group will go on to receive the MERITA treatment. It should be noted that these patients must have completed the 3-month visit before starting the MERITA treatment. This procedure ensures no bias when assessing the effectiveness of MERITA treatment.
- Conditions
- Domestic Violence, Psychotherapy, Group, Witness
- Being tested
- Emotional Regulation and Interpersonal Abilities group Therapy (MERITA)
- Keywords
- Domestic Violence, Witness, Psychotherapy, Group, Clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Regulation and Interpersonal Abilities group Therapy (MERITA)Behavioural
Therapy sessions Block 1. Recognition and verbalization of emotions: Session 1: Presentation, framing, and beginning of identification and denomination of emotions. Session 2: Recognition and differentiation of emotions. Session 3 and 4: Effects of traumatic experiences.
Block 2. Learning to manage emotions: Session 5: Managing unpleasant emotions, coping Abilities in body, mind, and behavior. Session 6: New coping skills, self-esteem. Session 7: New coping skills, self-care. Session 8: Skills for clear communication. Session 9: Assertiveness and reciprocity. Session 10: Save card and the good relations game/negotiation skills. Session 11: Social skills and confidence recovery. Session 12: Consolidation and farewell.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Emotional Regulation and Interpersonal Abilities group Therapy (MERITA). | 12 sessions of 75 minutes each and are carried out weekly. MERIT aims to improve emotional regulation, to cope with problems, promoting interpersonal skills and attachment security. Sessions will be lead by two psychologists with accredited experience in MERITA. Receives: Behavioral: Emotional Regulation and Interpersonal Abilities group Therapy (MERITA) | |
| Control: Treatment As Usual | The treatment as usual provided in children and adolescents who witnesses DV is mainly individual psychotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic symptoms
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Measured: Baseline
Post-traumatic symptoms
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Measured: Immediately after the intervention
Post-traumatic symptoms
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Measured: 3-month follow-up
Post-traumatic symptoms
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Measured: 6-month follow-up
Post-traumatic symptoms
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Measured: 12-month follow-up
Anxiety symptoms
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Measured: Baseline
Anxiety symptoms
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Measured: Immediately after the intervention
Anxiety symptoms
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Measured: 3-month follow-up
Anxiety symptoms
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Measured: 6-month follow-up
Anxiety symptoms
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Measured: 12-month follow-up
Depressive symptoms
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Measured: Baseline
Depressive symptoms
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Measured: Immediately after the intervention
Depressive symptoms
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Measured: 3-month follow-up
Depressive symptoms
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Measured: 6-month follow-up
Depressive symptoms
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Measured: 12-month follow-up
Emotional dysegulation
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Measured: Baseline
Emotional dysegulation
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Measured: Immediately after the intervention
Emotional dysegulation
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Measured: 3-month follow-up
Emotional dysegulation
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Measured: 6-month follow-up
Emotional dysegulation
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Measured: 12-month follow-up
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Measured: Baseline
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Measured: Immediately after the intervention
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Measured: 3-month follow-up
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Measured: 6-month follow-up
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Measured: 12-month follow-up
Secondary outcomes (15)
Somatic complaints
List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).
Measured: Baseline
Somatic complaints
List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).
Measured: Immediately after the intervention
Somatic complaints
List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).
Measured: 3-month follow-up
Somatic complaints
List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).
Measured: 6-month follow-up
Somatic complaints
List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).
Measured: 12-month follow-up
Child/adolescents attachment with mother and father
Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.
Measured: Baseline
Child/adolescents attachment with mother and father
Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.
Measured: Immediately after the intervention
Child/adolescents attachment with mother and father
Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.
Measured: 3-month follow-up
Child/adolescents attachment with mother and father
Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.
Measured: 6-month follow-up
Child/adolescents attachment with mother and father
Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.
Measured: 12-month follow-up
Family functioning
McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.
Measured: Baseline
Family functioning
McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.
Measured: Immediately after the intervention
Family functioning
McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.
Measured: 3-month follow-up
Family functioning
McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.
Measured: 6-month follow-up
Family functioning
McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Oct 2020
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917730
- Sponsor's protocol ID
- PIC-90-20
- Status last verified
- Apr 2024
- First submitted
- 2 Mar 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Promoting Emotional Regulation and Interpersonal Skills (MERITA) in Children and Adolescents Witnesses of Domestic Violence
- ClinicalTrials.gov ID
- NCT05917730
- Acronym / sponsor ID
- PIC-90-20
- Conditions
- Domestic Violence, Psychotherapy, Group, Witness
- Keywords
- Domestic Violence, Witness, Psychotherapy, Group, Clinical trial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
Domestic violence (DV) is a mental health problem that affects children and adolescents. Widespread evidence suggests that witnessing DV has physical and mental health consequences. 19% of children and adolescents cared for in Children, and Youth Mental Health Centers in Catalonia declare having witnessed DV between their parents. However, there are low specialized therapeutic tools to intervene effectively. In this line, the research team of the current project adapted and manualized a group treatment designed to treat children and adolescents between 8 and 16 years old witnesses of DV on an outpatient basis called: 'Manual of Emotional Regulation and Interpersonal Abilities group Therapy - MERITA'. The treatment main aim is to improve the emotional regulation and interpersonal skills of children and adolescents who have witnessed DV. We carried out a pilot study of MERITA (Lacasa et al., 2016) where we obtained promising results. Now, we want to carry out this study to improve methodological limitations by increasing the sample size. We have added a waiting list for assigning patients in different arms (MERITA intervention vs. treatment as usual as control group), as well as we improved the assessment (pre, post, and follow-ups) using several scales with good psychometric properties.
Aims:
The aim of this trial is twofold: firstly, to assess the effectiveness of Emotional Regulation and Interpersonal Abilities group Therapy (MERITA) in children and adolescents who are witnesses of DV and treated at the Infant and dolescent mental health center (TAU); and secondly, to analyze the differences (MERITA vs only TAU) on traumatic, depressive and anxious symptomatology, emotional dysregulation, interpersonal difficulties, externalizing and internalizing symptoms, somatic complaints, prosocial behavior, attachment, and family functioning. Specifically, MERITA will be compared to TAU alone (post and 3-month follow-up).
Methods
Design:
Trail with two arms:
- MERITA + TAU (intervention group)
- TAU (control group)
Sample:
The necessary sample size to detect statistically significant differences between the groups has been calculated using the G*Power: with a minimum effect size (0.50), a significance level of 5% and a power of 80%. A minimum of 36 participants would be required.
Detailed description
This clinical trial will be carried out with a group of children and adolescents who are witnesses of DV (between 8 and 16 years old). They will receive the MERITA treatment (together with TAU) and the other group will receive only TAU (control group).
The MERITA treatment consists of weekly 12 sessions of 75 minutes each. MERITA aims to improve emotional regulation and coping abilities, as well as promoting interpersonal skills and secure attachment.
After getting promising results from our previous pilot study of MERITA, the current project aims to validate, through a clinical trial with a control group, the MERIT treatment in minors who witness violence. To do this, children and adolescents who have undergone the MERIT will be compared with another group who receives other psychological and social approaches (treatment as usual), with other children and adolescents (same age and sex) who have only received treatment as usual.
The MERITA + TAU group and the TAU group will perform the following assessment: before treatment (baseline or pretreatment), after treatment (posttreatment), and at three months of follow-up. Specifically, the MERITA + TAU group will conduct two more assessments: at 6-month follow-up and one year of follow-up.
For ethical reasons, all patients will have the opportunity to use the MERITA treatment. Thus, the minors who were TAU group will go on to receive the MERITA treatment. It should be noted that these patients must have completed the 3-month visit before starting the MERITA treatment. This procedure ensures no bias when assessing the effectiveness of MERITA treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Emotional Regulation and Interpersonal Abilities group Therapy (MERITA). | – | Behavioral: Emotional Regulation and Interpersonal Abilities group Therapy (MERITA)12 sessions of 75 minutes each and are carried out weekly. MERIT aims to improve emotional regulation, to cope with problems, promoting interpersonal skills and attachment security. Sessions will be lead by two psychologists with accredited experience in MERITA. |
| Control: Treatment As Usual | – | –The treatment as usual provided in children and adolescents who witnesses DV is mainly individual psychotherapy. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient of a Child and Youth Mental Health Center.
Key inclusion criteria (4 listed)
- Patient of a Child and Youth Mental Health Center.
- Diagnosis of non-severe mental disorder according to DSM-5 (see exclusion criteria).
- Witness to violence at least in the last two years. A witness to violence is defined at least one of these characteristics (Holden, 2003; Suderman 1999): a) ocular witness of the violence; b) hear violent words or acts when she is in a nearby room; c) living the consequences of the violence without him having seen or heard anything, for example, when he finds that his mother is hurt, that she cries, that she tells him what has happened and that she wants to leave the house, or when he lives the police visit.
- Informed consent of the study signed by the guardian or legal representative.
Key exclusion criteria (5 listed)
- No signing the informed consent.
- Diagnosis of autism spectrum disorder, active psychotic disorders (schizophrenia, schizophreniform, schizoaffective, brief psychotic disorder, induced psychotic disorder), and severe eating disorder.
- Reason for consultation of forensic evaluation.
- Lack of clear collaboration of adults.
- IQ < 70.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Regulation and Interpersonal Abilities group Therapy (MERITA)Therapy sessions Block 1. Recognition and verbalization of emotions: Session 1: Presentation, framing, and beginning of identification and denomination of emotions. Session 2: Recognition and differentiation of emotions. Session 3 and 4: Effects of traumatic experiences. Block 2. Learning to manage emotions: Session 5: Managing unpleasant emotions, coping Abilities in body, mind, and behavior. Session 6: New coping skills, self-esteem. Session 7: New coping skills, self-care. Session 8: Skills for clear communication. Session 9: Assertiveness and reciprocity. Session 10: Save card and the good relations game/negotiation skills. Session 11: Social skills and confidence recovery. Session 12: Consolidation and farewell. | Behavioural | Experimental: Emotional Regulation and Interpersonal Abilities group Therapy (MERITA). |
Primary outcome
Post-traumatic symptoms
Time frame: Baseline
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Post-traumatic symptoms
Time frame: Immediately after the intervention
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Post-traumatic symptoms
Time frame: 3-month follow-up
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Post-traumatic symptoms
Time frame: 6-month follow-up
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Post-traumatic symptoms
Time frame: 12-month follow-up
Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.
Anxiety symptoms
Time frame: Baseline
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Anxiety symptoms
Time frame: Immediately after the intervention
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Anxiety symptoms
Time frame: 3-month follow-up
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Anxiety symptoms
Time frame: 6-month follow-up
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Anxiety symptoms
Time frame: 12-month follow-up
Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.
Depressive symptoms
Time frame: Baseline
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Depressive symptoms
Time frame: Immediately after the intervention
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Depressive symptoms
Time frame: 3-month follow-up
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Depressive symptoms
Time frame: 6-month follow-up
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Depressive symptoms
Time frame: 12-month follow-up
Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.
Emotional dysegulation
Time frame: Baseline
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Emotional dysegulation
Time frame: Immediately after the intervention
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Emotional dysegulation
Time frame: 3-month follow-up
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Emotional dysegulation
Time frame: 6-month follow-up
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Emotional dysegulation
Time frame: 12-month follow-up
Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Time frame: Baseline
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Time frame: Immediately after the intervention
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Time frame: 3-month follow-up
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Time frame: 6-month follow-up
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
Time frame: 12-month follow-up
Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.
15 secondary outcomes
Somatic complaints
Time frame: Baseline
Somatic complaints
Time frame: Immediately after the intervention
Somatic complaints
Time frame: 3-month follow-up
Somatic complaints
Time frame: 6-month follow-up
Somatic complaints
Time frame: 12-month follow-up
Child/adolescents attachment with mother and father
Time frame: Baseline
Child/adolescents attachment with mother and father
Time frame: Immediately after the intervention
Child/adolescents attachment with mother and father
Time frame: 3-month follow-up
Child/adolescents attachment with mother and father
Time frame: 6-month follow-up
Child/adolescents attachment with mother and father
Time frame: 12-month follow-up
Family functioning
Time frame: Baseline
Family functioning
Time frame: Immediately after the intervention
Family functioning
Time frame: 3-month follow-up
Family functioning
Time frame: 6-month follow-up
Family functioning
Time frame: 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Domestic Violence and Psychotherapy, Group, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic symptoms (time frame: Baseline). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.